Articles by Anna Rose Welch

  1. Overcoming CGT Potency Assay Woes: 4 Best Practices 12/21/2022

    Here, I share a few of the actionable takeaways I walked away with from the ARM/ASGCT potency assay working session in the hopes they will be a complementary exploration of the analytical challenge impacting every ATMP company.

  2. mRNA & RNA Therapeutics In 2023: Where Do We Go From Here? 12/7/2022

    To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.

  3. “Risky Business:” How Cell & Gene Therapies Are Upending Partnership Models 10/25/2022

    This article is the final installment of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.

  4. “Science Over Steel:” Exploring The Foundations Of A Hybrid CGT Outsourcing Strategy 10/11/2022

    This article is part one of a three-part series examining how advanced therapy scientific and quality-related challenges are impacting outsourcing models. We start first by unpacking the considerations ATMP innovators are faced with as they evaluate the increasingly popular hybrid outsourcing model.

  5. From Manufacturing To C-Suite: “Scaling Up” C&G Therapy Communication 6/20/2022

    Though "communicate often" is a commonly offered best practice in the CGT space, what is rarely discussed is what this can and should look like, especially when it comes to elevating information from the manufacturing floor/team up to the C-suite. Mark Gergen, CEO of Poseida Therapeutics, gives us a great idea of what this can look like for growing CGT companies.

  6. Can USP, NIST, & NIIMBL Conquer The Biggest AAV Quality Challenge? 5/18/2022

    As the CGT industry continues struggling to sufficiently characterize its AAV, USP's Fouad Atouf and I unpacked the ins-and-outs of this ongoing USP, NIST, and NIIMBL AAV quality initiative — as well as the CGT industry’s greatest needs from such a collaboration.

  7. A Different Perspective On The Current C&G Manufacturing Capacity Constraints 5/10/2021

    If you talk to anyone today about the decision behind constructing their own manufacturing facility, you’re likely to run into one of two big reasons spurring companies to make the investment in their own manufacturing footprint.

  8. Two Tips On Navigating C&G Outsourcing Relationships In A Competitive Landscape 5/4/2021

    It can be a bit overwhelming to keep tabs on all the movement occurring in the C&G industry today. You can’t open a newsletter or read an article without learning about company launches or acquisitions, clinical/manufacturing/regulatory milestones (or pitfalls), new partnerships, or facility ribbon cuttings/shutterings. While most of the glitzier headlines on C&G manufacturing highlight firms’ decisions to keep manufacturing in-house, outsourcing still plays — and will always play — a critical role in the development of these complex therapies.

  9. How To Approach C&G Therapy Outsourcing In The Make Vs. Buy Era 4/28/2021

    The world moves pretty fast — especially if you’ve been reading the many articles outlining the C&G industry’s feverish push to bolster and/or establish capacity.

  10. C&G Therapy Manufacturing Automation: Making The Most Of Today's Opportunities 3/17/2021

    While the future for automation in the C&G manufacturing process will no doubt be bright, a conversation with this cell therapy executive also emphasized just how important cultivating talent and carefully analyzing supply chain costs will be in the automation puzzle before us.